Nationwide Survey on Informed Consent and Ethical Review at Hospitals Conducting Post-marketing Studies Sponsored by Pharmaceutical Companies-Reference-Cited by-同舟云学术

Nationwide Survey on Informed Consent and Ethical Review at Hospitals Conducting Post-marketing Studies Sponsored by Pharmaceutical Companies

Published:2018-01-01 Issue:1 Volume:138 Page:63-71
ISSN:0031-6903
Container-title:YAKUGAKU ZASSHI
language:en
Short-container-title:YAKUGAKU ZASSHI

Author:

Urushihara Hisashi¹,Murakami Yuka¹,Matsui Kenji²,Tashiro Shimon³

Affiliation:

1. Division of Drug Development & Regulatory Science, Faculty of Pharmacy, Keio University

2. Department of Research Ethics and Bioethics, Research and Development Initiative Center, National Cerebral and Cardiovascular Center

3. Office for Bioethics, Center for Public Health Sciences, National Cancer Center

Publisher

Pharmaceutical Society of Japan

Subject

Pharmaceutical Science,Pharmacology

Link

https://www.jstage.jst.go.jp/article/yakushi/138/1/138_17-00109/_pdf

Reference15 articles.

1. 1) Pharmaceutical Affairs Bureau, Ministry of Health and Welfare, “Good Post-marketing Surveillance Practice for re-examination application of new drugs (Yaku-hatsu No. 646),” 1991.

2. 2) Ministry of Health, Labour and Welfare (MHLW), Good Post-marketing Study Practice for drugs (MHLW Ministerial Ordinance No. 171 of 2004), 2004.

3. 3) Ministry of Health and Welfare (MHW), Good Clinical Practice for Drugs (MHW Ministerial Ordinance of No. 28 of 1997), 1997.

4. 4) Pharmaceuticals and Food Safety Bureau, Ministry of Health, Labour and Welfare, “Guidance of Risk Management Planning for Pharmaceuticals (Yaku-shoku-an hatsu 0411 No.1, Yaku-shoku-shinsa hatsu 0411 No. 2, April 11, 2012),” 2012.

5. 5) Arima H., Kondo N., Tasaki M., Teramoto T., Mizui T., Watanabe T., J. Jpn. Soc. Hosp. Pharm., 52, 1234-1242 (2016).

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2. Survey of the Current Status of Ethical Review of Post-marketing Studies and the Issues at Tokai University Hospital;Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics;2020-09-30